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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K213388
Device Name AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Applicant
AngioDynamics, Inc.
603 Queensbury Ave
Queensbury,  NY  12804
Applicant Contact Kasey E. Newcomb
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave
Queensbury,  NY  12804
Correspondent Contact Kasey E. Newcomb
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received10/14/2021
Decision Date 04/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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